# Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS

Ossenkoppele, G J; Breems, D A; Stuessi, G; van Norden, Y; Bargetzi, M; Biemond, B J; et al; Chalandon, Y; Cloos, J; Deeren, D; Fehr, Mirjam; Pabst, Thomas; Manz, Markus G (2020). Lenalidomide added to standard intensive treatment for older patients with AML and high-risk MDS. Leukemia, 34(7):1751-1759.

## Abstract

More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy ("3 + 7") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m$^{2}$ twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).

## Abstract

More effective treatment modalities are urgently needed in patients with acute myeloid leukemia (AML) of older age. We hypothesized that adding lenalidomide to intensive standard chemotherapy might improve their outcome. After establishing a safe lenalidomide, dose elderly patients with AML were randomly assigned in this randomized Phase 2 study (n = 222) to receive standard chemotherapy ("3 + 7") with or without lenalidomide at a dose of 20 mg/day 1-21. In the second cycle, patients received cytarabine 1000 mg/m$^{2}$ twice daily on days 1-6 with or without lenalidomide (20 mg/day 1-21). The CR/CRi rates in the two arms were not different (69 vs. 66%). Event-free survival (EFS) at 36 months was 19% for the standard arm versus 21% for the lenalidomide arm and overall survival (OS) 35% vs. 30%, respectively. The frequencies and grade of adverse events were not significantly different between the treatment arms. Cardiovascular toxicities were rare and equally distributed between the arms. The results of the present study show that the addition of lenalidomide to standard remission induction chemotherapy does not improve the therapeutic outcome of older AML patients. This trial is registered as number NTR2294 in The NederlandsTrial Register (www.trialregister.nl).

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Contributors: the Dutch-Belgian Hemato-Oncology Cooperative Group (HOVON), Swiss Group for Clinical Cancer Research (SAKK) Journal Article, refereed, original work 04 Faculty of Medicine > University Hospital Zurich > Clinic for Oncology and Hematology 610 Medicine & health Health Sciences > Hematology Health Sciences > Oncology Life Sciences > Cancer Research English 1 July 2020 25 May 2020 09:20 29 Jul 2020 15:12 Nature Publishing Group 0887-6924 Closed Publisher DOI. An embargo period may apply. https://doi.org/10.1038/s41375-020-0725-0 32020044

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